FDA WARNING_LETTER - Fox Companies, LLC d/b/a Fox Cigar Bar - July 09, 2019
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The FDA issued a Warning Letter to Robert Fox of Fox Cigar on April 26, 2019, following a review of their website, foxcigar.com. The FDA determined that cigar products offered for sale, specifically the Julius Caeser Hail Caeser cigar, are tobacco products subject to FDA jurisdiction.
The primary violation identified was the sale of a misbranded tobacco product. The Julius Caeser Hail Caeser cigar was sold to a person younger than 18 years of age, which violates 21 U.S.C. § 387c(a)(7)(B) and 21 C.F.R. § 1140.14(b). Additionally, a complimentary Brick House Mighty Mighty Nat cigar was sent with the purchase. This constitutes misbranding under section 903(a)(7)(B) of the FD&C Act, as it violates regulations under section 906(d) of the FD&C Act, including 21 C.F.R. Part 1140.
Fox Cigar is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinued violative sales and
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